FEATURED EDITORIAL
Tales of purpose-led careers that bring innovations to business leaders and opportunities to university students. They inspire us. Chief Editor Louis Garguilo documents two such professionals who have combined to help domestic manufacturing organizations locate each other and power their operations, and to get students involved in the industry.
- Combination Cell Therapy's Clinical Success Hinges On Manufacturability
- Are Biopharma Companies Outsourcing Their Ability To Think?
- Global Ties, Good Fortune Bind Biotech And CDMO
- June 2026 — CDMO Opportunities And Threats Report
- The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
- Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
- Reshoring Pressure Meets Manufacturing Reality
GUEST COLUMNISTS
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Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
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June 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
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Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.
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Reshoring Pressure Meets Manufacturing Reality
U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.
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CDMO Live Europe 2026: Partnerships For An Uncertain World
112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.
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Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
Senior pharma leaders from Pfizer, Bayer, BioNTech and others debunk dual sourcing myths and reveal what separates strategic CDMO partnerships from transactional ones.
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Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.
PHARMA OUTSOURCING WHITE PAPERS
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Unlocking The Potential Of Biocatalysis
Biocatalysis delivers cleaner, more selective pharma processes while cutting energy use and waste. Engineered enzymes broaden their reach, enabling faster development and greater sustainability.
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ADCs As Biological Missiles For Targeted Therapies
Antibody-drug conjugates are reshaping cancer treatment. Learn how monoclonal antibody targeting, linker design, and next-gen payloads are defining the future of precision oncology.
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Solve ATMP Aseptic Filling Challenges With Gloveless Isolators
Human intervention is the top contamination risk in ATMP manufacturing. Robotic gloveless isolators address that risk through full automation and real-time monitoring during aseptic filling.
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AAV-Based Gene Editing For Huntington's Disease
LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.
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The TIDES Manufacturing Mandate: Why Incrementalism Fails And Integration Prevail
Manufacturing strategies for peptides and oligonucleotides are being reshaped by scale, complexity, and chronic use. An integrated, end‑to‑end approach shows how early design decisions can prevent costly bottlenecks later.
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2024 Global Biopharma Sustainability Review
What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 08.10.26 -- Mission-Driven Professionals And Students Build America's Supply Chains
- 08.08.26 -- Outsourced Pharma Newsletter - Best Of July
- 08.07.26 -- New Approaches To Accelerate Biologics Development
- 08.07.26 -- New Podcast Episodes: BoB@BIO, In Vivo Gene Editing, Multispecific Manufacturability, and More
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ON-DEMAND WEBINARS
- Controlling Nitrosamine Risk In Drug Products: Detection, Formation, And Control Strategies
- Enhancing AAV Manufacturing Yield Via Mini-Helper Plasmid
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